Calypte Reports Fourth Quarter and Full Year 2001 Financial Results; Revenues More than Double Compared With Prior Year.Business Editors ALAMEDA Alameda (ăləmē`də, –mā`də), city (1990 pop. 76,459), Alameda co., W central Calif., on an island just off the eastern shore of San Francisco Bay; settled 1850, inc. as a city 1884. , Calif.--(BW HealthWire)--Feb. 11, 2002 Calypte Biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. Corporation (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :CALY), a public healthcare company dedicated to the development and commercialization of urine-based diagnostic products and services, announced today that its revenues for the fourth quarter, ended December 31, 2001, increased by over 300% to $2,347,000, compared with $576,000 for the same period last year. Revenues for the full year, ended December 31, 2001, increased by 107%, reaching $6,826,000, compared with $3,296,000 for the year earlier period. The net loss for the fourth quarter decreased by $2,597,000 from a year ago. The net loss attributable to common stockholders for the fourth quarter of 2001 was $1,192,000, or $0.03 per share, compared with a net loss attributable to common stockholders of $3,789,000, or $0.15 per share, for the same quarter of 2000. The net loss attributable to common stockholders for the full year of 2001 was $9,248,000, or $0.30 per share, compared with a net loss attributable to common stockholders of $12,364,000, or $0.52 per share, for 2000. Both fourth quarter and full-year revenues represent records for Calypte. The net loss attributable to common stockholders decreased by 68% for the fourth quarter and by 25% for the full year compared with the same periods in 2000. The company also noted that it achieved a first-time-ever positive gross margin of $579,000, or 25%, for the fourth quarter of 2001, compared with a margin loss of $1,003,000, or -180%, in the comparable period in 2000. Full-year 2001 gross margin approached breakeven breakeven 1. The level of output or sales necessary to cover fixed expenses. Companies in industries that have high fixed costs and, consequently, high breakevens, such as automobile and steel manufacturing, are likely to exhibit large fluctuations at -2%, compared with a loss of 79% for 2000. Sales of HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. viral lysate ly·sate n. The cellular debris and fluid produced by lysis. , a component Calypte uses in the production of its Western Blot Western blot A technique developed in 1979 that is used to confirm ELISA results. HIV antigen is purified by electrophoresis and attached by blotting to a nylon or nitrocellulose filter. products and which it sporadically spo·rad·ic also spo·rad·i·cal adj. 1. Occurring at irregular intervals; having no pattern or order in time. See Synonyms at periodic. 2. Appearing singly or at widely scattered localities, as a plant or disease. sells to another manufacturer of serum-based HIV diagnostic tests and other parties, accounted for approximately 29% of Calypte's fourth quarter revenues, and approximately 20% of full year revenues. Because of the demand for, and unique nature of, this component, its sale generates a greater margin for Calypte than that of its completed test kits. The occurrence of these sales in the fourth quarter of 2001, coupled with the notable increases in sales of both urine- and serum-based diagnostic test kits, combined to generate the significant improvement in gross margin reported for the 2001 fourth quarter. Viral lysate sales accounted for 7% of full year, and 2% of fourth quarter sales, in 2000. Although Calypte expects sales of this component to continue periodically in 2002 and beyond, it does not at this time anticipate the same level of sales in 2002 as in the prior year. "We are very encouraged by our 2001 revenue increases and the corresponding margin improvement, said Nancy Katz, President and Chief Executive Officer of Calypte. "We believe this performance solidly validates both the increased acceptance of our products as well as the operational advances we have achieved in our manufacturing processes, and sets the stage for continuing progress." The company noted that both revenues and unit sales unit sales Sales measured in terms of physical units rather than dollars. Unit sales data are often used by financial analysts when evaluating the health of a company. of all of its continuing products increased in relation to the comparable prior year periods. Revenues from the sale of Calypte's urine HIV screening tests exceeded prior year results by 60% for the full year, and by 78% for the fourth quarter, due to expanded sales both domestically and internationally. Revenues from the sale of the urine supplemental tests increased similarly in both periods. In response to the company's resolution of the temporary product supply interruptions experienced during the third quarter, and the unparalleled levels of blood donations “Give blood” redirects here. For other uses, see Give blood (disambiguation). Blood donation is a process by which a blood donor voluntarily has blood drawn for storage in a blood bank, generally for subsequent use in a blood transfusion. in the aftermath of the September 11, 2001 terrorist attacks, fourth quarter 2001 revenues from the sale of its serum Western Blot product increased by nearly six times the level of the fourth quarter of 2000. Full year sales of the serum Western Blot test Western blot test n. A serum electrophoretic analysis used to identify proteins. more than doubled and demand for that product remains strong. The reduction in Calypte's burn rate observed in the first three quarters of 2001 continued through the fourth quarter. In addition to the improvement in margins, operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. decreased by $1,536,000 in 2001 compared to 2000 levels, with $1,032,000 of the decrease occurring in the fourth quarter. "2001 proved to be a pivotal year in Calypte's history," said Katz. "Beginning early in the first quarter, with the much-anticipated FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval of our Alameda facility, through our final record-breaking shipment in December, many critical aspects of our business was evolving and improving throughout the year. Sales to the reference labs supporting the domestic life insurance business increased by over 40% in 2001 compared to 2000. The major life insurance companies continue to expand their acceptance of urine testing as a part of their underwriting Underwriting 1. The process by which investment bankers raise investment capital from investors on behalf of corporations and governments that are issuing securities (both equity and debt). 2. The process of issuing insurance policies. standards and Calypte now counts nine of the ten `most admired' life insurance companies, as identified by Fortune magazine, as among those companies using its urine test to screen policy applicants. The addition of new customers such as Planned Parenthood Planned Parenthood A service mark used for an organization that provides family planning services. and Unilab, the largest testing lab in California, as well as the availability of our products in the public health arena through our new distributor, Meditech International, and the re-launch of our Sentinel Testing Service -- all of these events mark important expansions in Calypte's potential sales base, making our non-invasive diagnostic products increasingly available to clients of community-based and AIDS service organizations AIDS service organizations are community based that provide community support. While their primary function is to provide needed services to individuals with HIV, they also provide support services for their families and friends as well as conduct prevention efforts. , public health agencies and other organizations involved in STD testing An STD test is a medical test for the presence of any of a number of sexually transmitted diseases (STDs). Most STD tests are blood tests. STD tests may test for a single disease, or consist of a number of individual tests for any of a wide range of STDs, including tests for . "The unexpected increase in demand for our serum Western Blot test provided special opportunities successfully met by our Rockville manufacturing operation during 2001," Katz continued. "The new serum blot blot (blot) a technique for transferring ionic solutes onto a nitrocellulose membrane, filter, or treated paper for analysis; also used to describe the substrate containing the transferred material. distributor added during the first quarter of 2001 grew to become our single largest customer, accounting for 25% of our 2001 revenues. We look forward to sustaining and expanding this new relationship. The FDA approval of our Alameda facility in January 2001 enabled us to close the smaller Berkeley facility and achieve both cost savings and operational efficiencies in the production of our urine screening tests," Katz noted. "Although we made progress in our international distribution efforts in 2001, with notable shipments to our distribution partners in China, Malaysia, and sub-Saharan Africa, there remains much work to be done. We continue to focus significant effort on developing this component of our business," Katz continued, "and believe that great potential exists for expanded profitable distribution and other activities in these venues. Regulatory approval and compliance in these and other international locales, however, is often protracted pro·tract tr.v. pro·tract·ed, pro·tract·ing, pro·tracts 1. To draw out or lengthen in time; prolong: disputants who needlessly protracted the negotiations. 2. and, even following regulatory approval, completing the distribution infrastructure is time consuming. Calypte continues to pursue regulatory approvals and product evaluations in a number of countries, including the Philippines, South Korea, Thailand, Taiwan, Mexico and France. "In spite of severe cash flow difficulties during 2001," Katz said, "we recognized the importance of keeping a new product pipeline in process. To that end, we continued to focus on our most important new product development, a urine-based HIV 1/2 rapid test being developed in conjunction with our partner, SA Scientific, as well as pursuing strategic relationships that have the potential to expand the diagnostic value of a single urine specimen by testing for other diseases. We hope to have exciting news on these subjects in the near future." "As I look back over this past year, and review these accomplishments, I am honored to salute Calypte's employees for their dedication and creativity. In spite of resource constraints CONSTRAINTS - A language for solving constraints using value inference. ["CONSTRAINTS: A Language for Expressing Almost-Hierarchical Descriptions", G.J. Sussman et al, Artif Intell 14(1):1-39 (Aug 1980)]. in all areas of the operation, these talented people delivered record results by every measure," Katz observed. "As we move forward, we are again faced with challenging prospects. I am pleased to have Rick Brounstein working with us as Executive Vice President and CFO See Chief Financial Officer. , concentrating on capital formation opportunities and providing a stable financial base from which to move the business forward. "Based on our projections for both domestic and international growth, we expect another significant increase in revenues during 2002, and a strengthening of margins. Depending on the speed with which we can introduce potential new products, the level of regulatory and other front-end investment required to do so, as well as recognizing that many of those variables are not entirely within our control, we still are focused on attaining profitability sometime between the fourth quarter of 2002 and the third quarter of 2003. "However, as the company's cash on-hand as of December 31, 2001, was $287,000, and with negative working capital of $4.3 million, we will require additional external financing In the theory of capital structure, External financing is the phrase used to describe funds that firms obtain from outside of the firm. It is contrasted to internal financing which consists mainly of profits retained by the firm for investment. to continue the current level of operations through the first quarter of 2002. The company currently has cash balances of approximately $67,000. Calypte continues to draw on its equity line of credit and is actively pursuing both short-term and longer-term sources of financing, both domestically and abroad, that we believe will enable Calypte to continue its operations and achieve its milestones for 2002. There can, however, be no assurance that additional capital will be available to the company on acceptable terms, or at all," Katz concluded. Calypte Biomedical Corporation (OTC Bulletin Board OTC Bulletin Board An electronic quotation listing of the bid and asked prices of OTC stocks that do not meet the requirements to be listed on the NASDAQ stock-listing system. : CALY) headquartered in Alameda, California Alameda is a city in Alameda County, California, United States. It is located on a small island of the same name next to Oakland, California in the San Francisco Bay. An additional part of the city is Bay Farm Island, which is adjacent to the Oakland International Airport. , is a public healthcare company dedicated to the development and commercialization of urine-based diagnostic products and services for Human Immunodeficiency Virus human immunodeficiency virus n. HIV. Human immunodeficiency virus (HIV) A transmissible retrovirus that causes AIDS in humans. Type 1 (HIV-1), sexually transmitted diseases Sexually transmitted diseases Infections that are acquired and transmitted by sexual contact. Although virtually any infection may be transmitted during intimate contact, the term sexually transmitted disease is restricted to conditions that are largely and other infectious diseases infectious diseases: see communicable diseases. . Calypte's tests include the screening EIA (Electronic Industries Alliance, Arlington, VA, www.eia.org) A membership organization founded in 1924 as the Radio Manufacturing Association. It sets standards for consumer products and electronic components. and supplemental Western Blot tests, the only two FDA-approved HIV-1 antibody tests that can be used on urine samples. The company also markets one of only two FDA-approved HIV-1 supplemental Western Blot tests available for testing serum samples. The company believes that accurate, non-invasive urine-based testing methods for HIV and other infectious diseases may make important contributions to public health by helping to foster an environment in which testing may be done safely, economically, and painlessly pain·less adj. Free from complication or pain: a painless operation. pain  less·ly adv. . Calypte markets its products in over 40 countries worldwide
through international distributors and strategic partners.Statements in this press release that are not historical facts are forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. , including statements regarding future revenues and sales projections, plans for future financing, the ability to meet operational milestones, and shipments to and regulatory approvals in international markets. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, our ability to obtain additional financing that will allow us to continue our current and future operations and whether demand for our product in domestic and international markets will continue to expand. The company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances CIRCUMSTANCES, evidence. The particulars which accompany a fact. 2. The facts proved are either possible or impossible, ordinary and probable, or extraordinary and improbable, recent or ancient; they may have happened near us, or afar off; they are public or that occur after the date hereof here·of adv. Of this. hereof Adverb Formal or law of or concerning this Adv. 1. hereof - of or concerning this; "the twigs hereof are physic" or to reflect any change in the company's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact the company's success are more fully disclosed in the company's most recent public filings with the U.S. Securities and Exchange Commission ("SEC"), including its annual report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2000 and its subsequent filings with the SEC. Calypte Biomedical has scheduled a conference call featuring Nancy Katz, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. and President, and Rick Brounstein, EVP EVP Executive Vice President EVP EGR (Exhaust Gas Recirculation) Valve Position Sensor EVP Electronic Voice Phenomenon EVP Europäische Volkspartei (Germany) EVP Employee Value Proposition and CFO, to discuss financial results for the fourth quarter and full year of 2001 at 11:00 AM (EST EST electroshock therapy. EST abbr. electroshock therapy ) on Tuesday, February 12, 2002. All interested parties are invited to listen to this call. To listen to the call from the US, please dial 1-800-997-8642 and ask to be connected to the Calypte conference call. International callers please dial 1-973-694-2225. This conference call will also be webcast on the Internet. A link to a live broadcast of the call on the Internet can be found at "Investor" at www.calypte.com or at www.companyboardroom.com. If you are unable to participate, a rebroadcast of the call will be available beginning at 2:00 PM (EST) on Tuesday, February 12, 2002 until midnight Tuesday, February 19, 2002 (EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT ). To access the rebroadcast domestically, please dial: 1-800-428-6051, conference #: 230752. International callers please dial: 1-973-709-2089 and use the same conference number. To access a rebroadcast of the webcast, please visit "Investor" at www.calypte.com or visit www.companyboardroom.com.
CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
Unaudited
Three Months Ended Year Ended
December 31, December 31,
2001 2000 2001 2000
-------- -------- -------- --------
Revenues:
Product sales $ 2,347 $ 576 $ 6,826 $ 3,296
-------- -------- -------- --------
Cost of product
sales 1,768 1,579 6,986 5,891
-------- -------- -------- --------
Gross Margin (Loss)
on product sales 579 (1,003) (160) (2,595)
Other operating expenses:
Research and
development
costs 344 642 1,546 2,254
Selling, general
and administrative
costs 1,397 2,131 6,740 7,568
-------- -------- -------- --------
Total other
operating expenses 1,741 2,773 8,286 9,822
-------- -------- -------- --------
Loss from
operations (1,162) (3,776) (8,446) (12,417)
Interest income 1 43 9 289
Interest expense
(full year 2001
primarily non-cash) (16) (30) (1,373) (123)
Other income (expense) 15 4 539 9
-------- -------- -------- --------
Loss before
income taxes (1,162) (3,759) (9,271) (12,242)
Income taxes -- -- (2) (2)
-------- -------- -------- --------
Net loss before
extraordinary
item (1,162) (3,759) (9,273) (12,244)
Extraordinary
gain on repurchase
of beneficial
conversion feature,
net of tax expense -- -- 145 --
-------- -------- -------- --------
Net loss (1,162) (3,759) (9,128) (12,244)
Less dividends on
mandatorily
redeemable
Series A
preferred stock (30) (30) (120) (120)
-------- -------- -------- --------
Net loss attributable
to common
stockholders $ (1,192) $ (3,789) $ (9,248) $(12,364)
======== ======== ======== ========
Net loss per share
attributable to common
stockholders
(basic and diluted) $ (0.03) $ (0.15) $ (0.30) $ (0.52)
======== ======== ======== ========
Weighted average
shares used to
compute net loss
per share attributable
to common stockholders
(basic and diluted) 35,527 25,341 30,928 23,859
======== ======== ======== ========
CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARY
CONSOLIDATED BALANCE SHEET DATA
(in thousands)
Unaudited
December 31,
2001 2000
------- -------
Cash, cash equivalents, and restricted cash $ 287 $ 1,203
Working capital (4,289) (875)
Total Assets 4,262 5,006
Current portion of notes payable 411 471
Long-term portion of capital lease obligations 22 78
Mandatorily redeemable Series A preferred stock 2,456 2,336
Total stockholders' equity (5,500) (1,531)
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